FDA.reportPublic FDA data

Leica Biosystems

Primary DI
00849832013112
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
000000000003803815
Device description
Hematoxylin
Published
2024-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HYKHEMATOXYLIN HARRIS'S

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYKHematoxylin Harris'SHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849832013112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849832013112008498320131128498320131120849832013112

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Contacts#

Phone, Email table
PhoneEmail
+1(866)4783999tech.support@Leicabiosystems.com
+1(800)5374669tech.support@Leicabiosystems.com

Regulatory Flags#

DUNS number
082930884
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849832028345Leica Biosystems380365538036552026-10-13
10849832018619Leica Biosystems380077038007702026-10-13
10849832020360Leica Biosystems380079038007902026-10-13
10849832022968Leica Biosystems3800840E3800840E2026-10-13
10849832024122Leica Biosystems380078038007802026-10-13
10849832024153Leica Biosystems3800780AS3800780AS2026-10-13
10849832024306Leica Biosystems380081038008102026-10-13
10849832024368Leica Biosystems3800754AS3800754AS2026-10-13
10849832026904Leica Biosystems380084038008402026-10-13
20849832020343Leica Biosystems380081027AS380081027AS2026-10-13
20849832020350Leica Biosystems3800790BLK3800790BLK2026-10-13
20849832020695Leica Biosystems3800771BLK3800771BLK2026-10-13
20849832023092Leica Biosystems380075938007592026-10-13
20849832024105Leica Biosystems380079024AS380079024AS2026-10-13
20849832024112Leica Biosystems3800754BLK3800754BLK2026-10-13
20849832024396Leica Biosystems380075432AS380075432AS2026-10-13
20849832025676Leica Biosystems380077124AS380077124AS2026-10-13
00849832023036Leica Biosystems380085038008502026-10-12
00849832023043Leica Biosystems380085438008542026-10-12
00849832023050Leica Biosystems380085238008522026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849832002611Leica BiosystemsLeica Biosystems Richmond, Inc.HYK2024-12-16
00673693088039EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04
00673693088046EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04
00673693088060EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04
00673693228398EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04
00673693228404EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04
00673693228411EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04
00673693228428EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04
00673693228497EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04